Mintz Levin - Health Law & Policy Matters

New Materials Help Covered Entities Comply with Nondiscrimination Rules

Last week, the Department of Health and Human Services (“HHS”) released new materials for covered entities to use to comply with Section 1557, the nondiscrimination provision of the Affordable Care Act. Section 1557 strengthens…more
| Civil Rights, Health

FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations

In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous…more
| Health, Science, Computers, & Technology

FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests

On July 14, 2016, the U.S. Food and Drug Administration (the “FDA”) released draft guidance on the codevelopment of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the therapeutic…more
| Health, Science, Computers, & Technology

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally…more
| Health, International Law & Trade, Science, Computers, & Technology

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016 State…more
| Administrative Law, Elections & Politics, Health, Science, Computers, & Technology

OCR Sends Notification Letters to Phase 2 HIPAA Auditees

On July 12, 2016, HHS’s Office for Civil Rights (OCR) distributed an e-mail discussing recent developments in Phase II of its HIPAA audit program…more
| Health, Privacy

CMS Releases Proposed Outpatient Payment System Rule for 2017, Leaving Hospitals Unhappy

Last week, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System for 2017. CMS…more
| Government Contracting, Health

D.C. Circuit Strikes a Potential Blow to the Affordable Care Act

Earlier this month, the Court of Appeals for the D.C. Circuit issued its decision in Central United Life Insurance Co., v. Burwell, striking down a Department of Health and Human Services (HHS) rule prohibiting the sale and…more
| Health

“Your Money or Your PHI”: OCR Releases Guidance on Ransomware

On July 11, 2016, the Office for Civil Rights (OCR) released important new guidance on ransomware for hospitals and other healthcare providers and finally addressed the question of whether electronic protected health information…more
| Consumer Protection, Privacy, Health, Science, Computers, & Technology

Biodiagnostic Laboratory Services Sentenced; Another Physician Pleads Guilty

The long-running test-referral prosecution against Biodiagnostic Laboratory Services, LLC (“BLS”), a New Jersey clinical blood testing laboratory; its owner and employees; and BLS’s referring physicians recently reached another…more
| Commercial Law & Contracts, Criminal Law, Health, Science, Computers, & Technology

Senate Committee Releases Report on Potential Stark Law Changes, Hearing Scheduled

On June 30, 2016, the Senate Finance Committee’s Republican staff issued a 20-page report discussing comments made by industry stakeholders after a December 2015 round-table on the future of the physician self-referral law, also…more
| Civil Remedies, Commercial Law & Contracts, Elections & Politics, Health

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new abbreviated…more
| Civil Procedure, Civil Remedies, Health, Intellectual Property, Science, Computers, & Technology

OIG Advisory Opinion Approves Drug Discount Program

Last week, the OIG posted favorable advisory opinion (16-07) regarding a proposed discount program for Part D beneficiaries who are prescribed a statutorily excluded erectile dysfunction drug. The OIG concluded that while the…more
| Health, Science, Computers, & Technology

Texas Medical Board Seeks State Action Immunity Protection in Fifth Circuit Brief

On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the case…more
| Administrative Law, Antitrust & Trade Regulation, Health, Science, Computers, & Technology

DOJ Announces Dramatic Increase in False Claims Act Penalties

On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim penalties…more
| Business Torts, Government Contracting, Health
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